AIRTRAQ SP AIRTRAQ AVANT

K121378 · Prodol Meditec , Ltd. · CCW · Jun 21, 2012 · Anesthesiology

Device Facts

• Record ID: K121378
• Device Name: AIRTRAQ SP AIRTRAQ AVANT
• Applicant: Prodol Meditec , Ltd.
• Product Code: CCW · Anesthesiology
• Decision Date: Jun 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5540
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

Airtraq® SP - MR and Airtraq® Avant are intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Device Story

Airtraq® SP-MR and Airtraq® Avant are rigid optical laryngoscopes designed for tracheal intubation within MR environments (up to 3.0 Tesla). The device features an anatomically shaped blade with a guide channel for loading and advancing an endotracheal (ET) tube. The clinician visualizes the airway anatomy and glottis opening through the device's optical system to guide intubation. The SP model is a single-patient, disposable unit powered by non-magnetic AAA batteries. The Avant model consists of a reusable optical component (containing lenses, mirrors, rechargeable non-magnetic battery, LED light, heater, and diagnostic PCB) and a single-use disposable blade. The device aids clinicians in securing the airway in MR settings, potentially improving intubation success and patient safety during procedures requiring MR imaging.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, specifically performance testing according to ASTM F2052-02 to ensure safety in a 3.0 Tesla magnetic field (deflection < 45 degrees).

Technological Characteristics

Rigid laryngoscope; non-magnetic materials; LED illumination; integrated heater; optical system (lenses/mirrors). SP model: disposable, AAA battery-powered. Avant model: reusable optical module, rechargeable battery, disposable blade. ASTM F2052-02 testing for MR compatibility. No software/algorithm.

Indications for Use

Indicated for patients requiring tracheal intubation in Magnetic Resonance (MR) environments up to 3.0 Tesla.

Regulatory Classification

Identification

A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

Predicate Devices

• Truphatek Tru-MR™ (K062523)

Submission Summary (Full Text)

{0}------------------------------------------------

Premarket Notification 510(k) Section 5 - 510(k) Summary

r

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Airtraq® MR

#### 510(k) Summarv K 12137 Page 1 of 3 06-May-2012

JUN 2 1 2012

Prodol Meditec Ltd. 1/F Block C, No.18 7th Science Ave. Hi-Tech Innovation Coast Tangjia Bay Zhuhai, 519085 China PR

| Official Contact: | Tanya Tan – General Manager<br>Tel [phone]<br>Fax [phone] |
|----------------------------|-------------------------------------------------------------------------------|
| Proprietary or Trade Name: | Airtraq® SP – MR<br>Airtraq® Avant |
| Common/Usual Name: | Rigid Laryngoscope |
| Classification Name: | Rigid Laryngoscope<br>Product code – CCW<br>21 CFR 868.5540<br>Class 1 |
| Predicate Devices: | Truphatek Tru-MR™ – K062523 |

## Device Description:

Airtraq® Optical laryngoscope is an anatomical shaped rigid laryngoscope which allows the user to see the airway anatomy during insertion and intubation. It is designed with a guide channel in which one loads the endotracheal tube ("ET tube") that is then advanced once the glottis opening has been identified and centered in the view field of the Airtraq® optics. Prodol Meditec offers two (2) models.

# Airtraq® SP - single patient

This model is a completely self-contained unit that operates on standard non-magnetic AAA batteries. It is a single patient use, disposable.

### Airtraq® Avant

A vant once assembled is identical in its design and function as the Airtraq@ SP model.

Avant is designed as 2 components unlike the Airtraq® SP model.

- 1. Optics This is a limited life reusable components which contains the lenses and mirrors of the optical system plus the rechargeable, non-magnetic battery, and PCB which controls the LED light, heater and diagnostics for the battery.
- 2. Blade There are 2 blade sizes, Regular (ET tube size 7.0 mm to 8.5 mm) and Small (ET tube 6.0 mm to 7.5 mm). These are single use disposables in which the Optics are inserted and then the assembled device used. There is an eye cap that incorporates a protective lens that fits over the Optics once it has been inserted into the Blade.

{1}------------------------------------------------

# 510(k) Summary Page 2 of 3 06-May-2012

## Indications for Use:

(

Airtraq® SP – MR and Airtraq® Avant are intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

## Patient Population:

Patients who are to be intubated as determined by the clinician.

### Environment of Use:

Adding Magnetic Resonance (MR) environments up to 3.0 Tesla strength.

## Comparison to Predicates

| Features | Truphatek<br>Tru-MRTM K062523 | Proposed Device<br>Airtraq® SP –MR<br>Airtraq® Avant |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Tru-MR TM laryngoscope set is<br>used to facilitate and aid in tracheal<br>intubation in a Magnetic Resonance<br>(MR) environment, not to exceed a<br>3.0 Tesla static magnetic field. | The Airtraq® SP – MR and Avant<br>are intended to facilitate and aid in<br>tracheal intubation in a Magnetic<br>Resonance (MR) environment, not<br>to exceed a 3.0 Tesla static<br>magnetic field. |
| Environment of Use | MR environments<br>Not to exceed 3.0 Tesla | Same<br>Not to exceed 3.0 Tesla |
| Patient Population | Patients to be intubated | Patients to be intubated |
| Configurations | Handles<br>Battery<br>Blades | Airtraq® SP MR<br>Blade<br>AAA Battery<br>Internal Optics<br><br>Airtraq® Avant<br>Blade<br>Reusable Optics<br>Rechargeable battery |
| Performance<br>Testing | ASTM F2052-02<br>Standard Test Method of<br>Magnetically Induced<br>Displacement Force of Medical<br>devices in the Magnetic Resonance<br>Environment<br>Pass criteria is deflection of < 45<br>degrees | ASTM F2052-02<br>Standard Test Method of<br>Magnetically Induced<br>Displacement Force of Medical<br>devices in the Magnetic Resonance<br>Environment<br>Pass criteria is deflection of < 45<br>degrees |

{2}------------------------------------------------

## 510(k) Summary Page 3 of 3 06-May-2012

### Substantial Equivalence Discussion

The Airtrag® SP - MR and Airtraq® Avant optical laryngoscopes are viewed as substantially equivalent to the predicate device because:

#### Indications -

1

- . Identical to predicate - K062523
- Intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) . environment, not to exceed a 3.0 Tesla static magnetic field.

#### Technology -

- . Similar - handle, battery, blade design to predicate - K062523
- Both devices are Class 1 exempt from PMN .

#### Materials -

- . The materials are part of a Class I exempt device.
#### Environment of Use -

- Identical to predicate K062523 .
- Adding Magnetic Resonance (MR) environments up to 3.0 Tesla strength. .

### Patient Population -

- Identical to predicates K062523 .
- . Patients who are to be intubated

### Performance Testing

- · Identical to predicate K062523
- Testing has been performed according to ASTM F2052-02 for deflection in a 3.0 Tesla . environment

{3}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of a stylized eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 2 1 2012

Prodol Meditec Limited C/O Mr. Paul E. Dryden Authorized Representative Airtraq LLC 24301 Woodsage Drive Bonita Springs, Florida 34134

Re: K121378

Trade/Device Name: Airtraq® SP MR, Airtraq® Avant Regulation Number: 21 CFR 868.5540 Regulation Name: Rigid Laryngoscope Regulatory Class: I Product Code: CCW Dated: May 6, 2012 Received: May 21, 2012

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{4}------------------------------------------------

# Page 2 – Mr. Dryden

Enclosure

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm1 for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Th for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{5}------------------------------------------------

# Indications for Use Statement

510(k) Number:

K121378 (To be assigned)

Device Name:

Airtraq® SP MR Airtraq® Avant

# Indications for Use:

Airtraq® SP - MR and Airtraq® Avant are intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

Page 1 of 1

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schult

(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices

510(k) Number: K121378